MCHUPF: Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

Sponsor

Syamsudin Abdillah,Ph.D, Pharm D (Other)

Overall Status

Completed

CT.gov ID

NCT05829187

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. A study is conducted to assess the efficacy and safety extract of bitter melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum uncomplicated in Sumba Barat Daya District, Indonesia

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Plasmodium Falciparum	Drug: Dihydroartemisinin Drug: Piperaquine Drug: Primaquine Drug: Momordica Charantia Extract	Phase 2

Detailed Description

The Study was conducted in Kori Primary Health Cender, Sumba Barat Daya District, East Nusa Tenggara Province on Sumba Island.

The study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1 day on first day (DHP+PQ) or extract of bitter melon (Momordica charantia/MC) + Placebo 1 day on first day according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa stained tihick blood films to detect Plasmodium falciparum infection.

All Patient were allocated by single blind randomization to receive DHP (on day 0 to day 2)+PQ (on day 0 only) or extract of bitter melon (Momordica charantia/MC) (on day 0 to day 2)+placebo (on day 0 only). The procedures of drug administration in the study were as follows:

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

the patient comes to the primary health care facility, is examined by a doctor, if malaria is suspected, a parasite examination is carried out in the laboratory. If positive for falciparum malaria and based on the results of the doctor's examination meet the criteria as research subjects, then the drug is given based on the random table that has been provided.the patient comes to the primary health care facility, is examined by a doctor, if malaria is suspected, a parasite examination is carried out in the laboratory. If positive for falciparum malaria and based on the results of the doctor's examination meet the criteria as research subjects, then the drug is given based on the random table that has been provided.

Masking:

Single (Participant)

Masking Description:

The test drug and the control drug are put into the capsule with the same weight, type and smell so that the patient cannot distinguish between the test drug and the control drug

Primary Purpose:

Treatment

Official Title:

Effectiveness of Momordica Charantia Extract Compared to the Standard Antimalarial Drug Combination Dihydroartemisinin Piperaquine-primaquine in Patients With Uncomplicated Falciparum Malaria, in Sumba Barat Daya District of Indonesia

Actual Study Start Date :

Nov 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25.	Drug: Dihydroartemisinin dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days Other Names: 1st group Drug: Piperaquine piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days Other Names: 1st group Drug: Primaquine Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only Other Names: 1st Group
Experimental: Extract Capsul Momordica Charantia Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days.	Drug: Momordica Charantia Extract Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days Other Names: 2nd group

Arm

Intervention/Treatment

Experimental: Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25.

Drug: Dihydroartemisinin

dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days

Other Names:

1st group

Drug: Piperaquine

piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days

Other Names:

1st group

Drug: Primaquine

Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Other Names:

1st Group

Experimental: Extract Capsul Momordica Charantia

Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days.

Drug: Momordica Charantia Extract

Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days

Other Names:

2nd group

Outcome Measures

Primary Outcome Measures

development of sexual and asexual stages of Plasmodium falciparum [28 day post treatment]
Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smear were stained with 3% giemsa solution for 45 minutes and were read under binocular microscope with 1,000x magnification

Secondary Outcome Measures

Parasite clearence times [28-days]
parasite reduction ratio
Fever clearence time [28 days]
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
Number of adverse event [28 days]

Other Outcome Measures

Measure imunomodulator Effect [1x24 hour before and after treatment]
Measuring the immunomodulatory effect by measuring the levels of TNF alpha and interferon gamma cytokines before and after the treatment intervention 1 x 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:-

Age ≥ 18 years old male or female up to 60 years old
Single Plasmodium falciparum infection based on microscopic examination.
Count the parasites for Plasmodium falciparum at least 2 large visual field asexual parasites (LPB) by examining 15 LPB
Density of parasites 1000-100,000/micro liter
Has no history of uncontrolled comorbidities
History of fever in the last 24 hours for falciparum malaria
Not taking other antimalarial drugs in the last 2 weeks.
Have no previous history of malaria.
Willing to come to the health facility according to the specified follow-up schedule.
Willing to participate in research and established procedures.
There is no history of allergy to antimalarial drugs.

Exclusion Criteria:

Signs of general weakness, or decreased consciousness or recurrent seizures or circulation failure or pulmonary edema or signs of anemia or yellow body and slightly red urine.
If the examination results show mixed Plasmodium and non-Plasmodium falciparum.
Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances.
Does not control regularly according to the research schedule
Pregnant and lactating women
There are signs of severe malaria
Patients with chronic diseases, for example: heart, kidney, liver, HIV.
Mixed infection.